Teams at Aura Biosciences

Provides GCP quality oversight for clinical trials, leads audits of sites, CROs, vendors, TMFs, and internal processes, and oversees quality events, investigations, CAPAs, and remediation. Supports clinical QMS development, inspection readiness, regulatory inspections, risk-based document reviews, training, and quality metrics. Requires strong knowledge of global clinical research regulations and willingness to travel domestically and internationally for audits.

Provides strategic oversight and governance of Trial Master Files across clinical studies. Ensures complete, accurate, inspection-ready documentation compliant with ICH-GCP, regulations, and SOPs. Oversees eTMF systems, CRO and vendor relationships, TMF reviews, reconciliations, metrics, inspections, audits, training, and CAPA activities. Collaborates with clinical, regulatory, quality, biostatistics, data management, and pharmacovigilance teams, while potentially managing or mentoring TMF staff.